Future Clinical Chemistry and Immunodiagnostics Markets: Growth Opportunities and Business Expansion Strategies

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Future Clinical Chemistry and Immunodiagnostics Markets: Growth
Opportunities and Business Expansion Strategies
Published on November 2011

Report Summary

During the next decade, the clinical chemistry and immunodiagnostics markets will undergo significant transformation. The changes
will be caused convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering,
automation, and IT; and intensifying competition. Some segments, like routine chemistry, will resemble commodity markets, where
product positioning and cost per test are more critical than underlying technology. This evolving marketplace will create exciting
opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices,
controls, calibrators and others.

"The Clinical Chemistry and Immunodiagnostics Markets" is a unique worldwide market intelligence and technology assessment study
designed to help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective
strategic responses. The study explores future trends in the U.S., five major European countries and Japan; provides estimates of
the specimen, test and sales volumes, as well as major suppliers' sales and market shares; compares features of leading analyzers;
profiles key competitors; and identifies specific product and marketing opportunities facing suppliers during the next ten years.
Contains 1,115 pages and 450 tables

Table of Content

Table of Contents

Introduction
Worldwide Market and Technology Overview
A. Major Routine Chemistry Tests
1. Albumin
2. Alkaline Phosphatase
3. ALT/SGPT
4. Ammonia
5. Amylase
6. AST/SGOT
7. Bilirubin
8. Blood Gases
9. Blood Urea Nitrogen (BUN)
10. Calcium
11. Cholesterol
12. Cholinesterase
13. Creatinine
14. Electrolytes
a. Carbon Dioxide/Bicarbonate
b. Chloride

Future Clinical Chemistry and Immunodiagnostics Markets: Growth Opportunities and Business Expansion Strategies (From Slideshare) Page 1/23


c. Potassium
d. Sodium
15. Fructosamine
16. Gamma-Glutamyl Transpeptidase (GGT)
17. Glucose
18. High Density Lipoprotein (HDL)
19. Iron
20. Lactate Dehydrogenase (LDH)
21. Magnesium
22. Phosphorus
23. Protein
24. Triglycerides
25. Uric Acid
26. Troponin
B. Therapeutic Drug Monitoring (TDM)
1. Overview
2. Carbamazepine
3. Digoxin
4. Gentamicin
5. Lidocaine
6. Lithium
7. Phenytoin/Dilantin
8. Procainamide
9. Quinidine
10. Theophylline
11. Valproic Acid
C. Endocrine Function Tests
1. Cortisol
2. Follicle-Stimulating Hormone (FSH)
3. Gastrin
4. Human Chorionic Gonadotropin (HCG)
5. LH
6. Prolactin
7. T3
8. T3 Uptake
9. Free T3
10. Thyroxine (T4)
11. Free T4
12. TBG
13. TSH
D. Tumor Markers And Special Chemistry Tests
1. Alpha-Fetoprotein (AFP)
2. Carcinoembrionic Antigen (CEA)
3. Ferritin
4. Follate/Folic Acid
5. Occult Blood
6. Prostatic Acid Phosphatase (PAP)
7. Prostate-Specific Antigen (PSA)



8. Vitamin B-12
E. Immunoprotein Tests
1. Complement
a. C3
b. C4
2. CRP
3. Immunoglobulins (IgA, IgE, IgG, IgM)
4. Protein Electrophoresis
F. Drugs of Abuse
1. Overview
2. Test Methodologies
3. Amphetamines
4. Barbiturates
5. Benzodiazepines
6. Cannabinoids/Marijuana
7. Cocaine
8. Lysergic Acid Diethylamide (LSD)
9. Methadone
10. Methaqualone
11. Opiates
12. Phencyclidine
G. Instrumentation Review
Abaxis Piccolo
Abaxis Piccolo Xpress
Abbott AxSYM
Abbott Architect c4000
Abbott Architect i2000 Series
Abbott Architect ci8200 System
Abbott i-STAT
Alfa Wassermann ACE Alera
AMS Liasys
Awareness Technologies ChemWell
Awareness Technology STAT FAX 4500
Beckman Coulter Unicel Series
Beckman Coulter Access
Binding Site ESP600
bioMerieux Mini Vidas
Carolina Chemistries BioLis 24i
DiaSorin Liaison
Grifols Triturus
Horiba ABX Pentra 400
Inverness DS2
J&J DT System
J&J Vitros ECi/ECiO
J&J Vitros 3600
J&J Vitros 5600
Medica EasyRA
Nova Biomedical Critical Care Xpress



Olympus AU480
Olympus AU5400
Olympus AU53000i
Olympus AU2700
Polymedco Poly-Chem
Polymedco Spotchem EZ
Randox RX Daytona
Randox RX Imola
Roche Modular Analytics
Roche Cobas Integra 400
Roche Cobas Integra 400 Plus
Roche Elecsys
Roche Cobas c311
Roche Cardiac 200
Siemens ADVIA Centaur
Siemens Dimension
Siemens Dimension RxL Max
Siemens Dimension Vista 500
Siemens Immulite
Siemens Stratus
Tosoh AIA-Series
Vital Diagnostics ATAC 8000
Vital Diagnostics Envoy 500
H. Major In Vitro Diagnostic Technologies
And Their Potential Applications
1. Monoclonal and Polyclonal Antibodies
2. Immunoassays
a. Technological Principle
b. Radioimmunoassays (RIA)
c. Enzyme Immunoassays (EIA)
Overview
ELISA
EMIT
Immunofiltration
Dot Immunobinding Assays
Capillary Immunoassays
Particle-Membrane Capture Immunoassays
Enzyme Amplification
CEDIA
Electrochemical Immunoassays
d. Fluorescent Immunoassays
Fluorescence Polarization
Time-Resolved Pulse Fluorescence
e. Luminescence
Chemiluminescence
Bioluminescence
f. Latex Agglutination
g. Immunoprecipitation



h. Affinity Chromatography Immunoassays
i. Liposome Flow-Injection Immunoassays
3. IT and Automation
4. Dry Chemistry
5. Biosensors
6. Robotics
7. Chemometrics
8. Molecular Diagnostics
a. Sample Preparation
b. Hybridization
c. Separation
d. Detection/Measurement
Test Formats
a. Filter Hybridization
b. Southern Blot
c. Northern Blot
d. In Situ Hybridization
e. Others
Labeling Techniques
Amplification Methods
Polymerase Chain Reaction
- Temperature Cyclers
- PCR Variations
Immuno-PCR
QC-PCR.
DAP-PCR
Strand Displacement Activation
TMA
Ligase Chain Reaction
Branched DNA
- Hybridization Protection Assay
Nucleic-Acid Sequence-Based Amplification
Self-Sustained Sequence Replicase
Others
- Ampliprobe
- CAR
- CAS
- CPT
- Dendritic Polymer Technology
- ISO-CR
- LAT
- Probe Networks
- RAMP
- Repair Chain Reaction
- Rolling Circles
- Sequence Independent Gene Amplification
- Sequence Initiation Reaction
- SISPA



- Solid Phase Amplification
Detection Technologies
a. Radioactive Methods
Overview
Major Isotopes
- P-32
- S-35
- H-3
- I-125
b. Non-Isotopic Methods
Enzymatic Labels
Chemical Labeling
- Indirect Chemical Labeling
- Direct Chemical Labeling
Fluorescence
Chemiluminescence
Electrical Conductivity
Instrumentation Review
a. Abbott LCx
b. Beckman Coulter/Biomek FK
c. Becton Dickinson SDA
d. Bio-Rad GeneScope
e. Gen-Probe Tigris
f. Roche Cobas Amplicor
g. Tecan LS Series
Biochips: Genosensors, Microarrays, and
Labs-on-the-chip
- Liquid Transportation and Mixing
- Separation
- Reaction
- Detection
Worldwide Market Overview
1. Business Environment
2. Market Structure
3. Market Size and Growth
France
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth and Major Suppliers'
Instrument and Reagent Sales and Market Shares
Germany
C. Market Structure
Italy



C. Market Structure
Japan
C. Market Structure
Spain
C. Market Structure
U.K.
C. Market Structure
U.S.A.
1. Health Care Expenditures
2. Cost Consciousness
3. Industry Consolidation
4. Managed Care
5. Hospitals
6. Admissions
7. Length of Stay
8. Industry Diversification
9. Physician Demographics
10. Population Aging
a. Chronic Illness
b. Disease Incidence
c. Susceptibility to Iatrogenesis
d. Multiple Illness Cases
11. Laboratory Regulations
C. Market Structure
1. Centralized Testing
a. Hospitals
b. Commercial/Private Laboratories
2. Decentralized Testing
a. Physician Offices/Group Practices
b. Point-of-Care Testing



c. Home/Self Testing
d. Other Decentralized Testing Locations
Major Product Development Opportunities
Design Criteria for Decentralized Testing Products
Alternative Market Penetration Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies for Decentralized
Testing Markets
1. Marketing Approaches
2. Product Complexity
3. Customer Preference
4. Established Suppliers
5. Emerging Suppliers
6. Major Types of Distributors
7. Market Segmentation
Potential Market Entry Barriers and Risks
A. Market Maturity
B. Cost Containment
C. Competition
D. Technological Edge and Limitations
E. Patent Protection
F. Regulatory Constraints
G. Decentralized Testing Market Challenges
Competitive Assessments
- Abbott Laboratories
- AdnaGen
- Ambrilia
- AMDL
- Beckman Coulter
- Biomedical Diagnostics
- BioMerieux
- Bio-Rad
- Canag Diagnostics
- Dako
- DiaSorin
- Eiken
- Fujirebio
- Instrumentation Laboratory
- J&J
- Kyowa Medex
- Matritech
- Roche
- Siemens
- Sysmex



- Thermo Fisher
- Trinity Biotech
- Tosoh
- Wako
- Wallac

List of Tables
Major Companies Developing or Marketing
Albumin Tests
Alkaline Phosphatase Tests
ALT/SGPT Tests
Amylase Tests
AST/SGOT Tests
Bilirubin Tests
Blood Gas Analyzers
BUN Tests
Calcium Tests
Cholesterol Tests
Creatinine Tests
Electrolyte Tests
GGT Tests
Glucose Tests
HDL Tests
Iron Tests
LDH Tests
Magnesium Tests
Phosphorus Tests
Protein Tests



Triglycerides Tests
Uric Acid Tests
TDM Tests
Digoxin Tests
Lithium Tests
Phenytoin/Dilantin Tests
Theophylline Tests
Valproic Acid Tests
FSH Tests
HCG Tests
LH Tests
Prolactin Tests
T3 Tests
T4 Tests
TSH Tests
AFP Tests
CEA Tests
Ferritin Tests
Occult Blood Tests
Prostatic Acid Phosphatase Tests
PSA Tests
Vitamin B-12/Folate Tests
CRP Tests
Drugs of Abuse Tests



Biosensors for Clinical Chemistry Testing
Biosensors for Immunological Testing
DNA Probes for Cancer Testing
DNA Probes for Genetic Disease Testing
Worldwide, All Market Segments, Estimated
Laboratory Universe Performing Chemistry
and Immunodiagnostics Tests By Country
Chemistry and Immunodiagnostics Consumable
Market By Country
Chemistry and Immunodiagnostics Instrument Sales
By Country
Worldwide, All Market Segments, Estimated Total
Chemistry and Immunodiagnostics Market
By Country
Executive Summary Table: France, Clinical
Chemistry and Immunoassay Test Volume and
Diagnostics Sales Forecast By Test Category
France, Laboratories Performing Chemistry
and Immunoassay Tests By Market Segment
France, Hospital Laboratories Performing
Chemistry and Immunoassay Tests
By Bed Size
France, Commercial/Private Laboratories
Performing Chemistry and Immunoassay
Tests By Annual Test Volume
France, Total Chemistry and Immunoassay
Specimen Volume Forecast
France, All Market Segments, Specimen
Volume Forecast By Test Category
France, Total Clinical Chemistry and
Immunoassay Test Volume Forecast By Test Category
France, Routine Chemistry Test Volume
Forecast By Market Segment
France, Endocrine Function Test Volume
France, Tumor Markers and Special Chemistry
Test Volume Forecast By Market Segment
France, Immunoprotein Test Volume Forecast
By Market Segment
France, TDM Test Volume Forecast By Market Segment
France, Drugs of Abuse Test Volume Forecast
By Market Segment
France, All Market Segments, Profiles,



Panels and Individual Tests Forecast
France, Hospital Laboratories, Profiles,
France, Commercial/Private Laboratories,
Profiles, Panels and Individual Tests Forecast
France, All Market Segments, Routine
Chemistry Test Volume Forecast by Assay
France, Hospital Laboratories, Routine
Routine Chemistry Test Volume Forecast by Assay
France, All Market Segments, Endocrine
Function Test Volume Forecast by Assay
France, Hospital Laboratories, Endocrine
Endocrine Function Test Volume Forecast by Assay
France, All Market Segments, Tumor Markers
and Special Chemistry Test Volume Forecast by Assay
France, Hospital Laboratories, Tumor Markers
Tumor Markers and Special Chemistry Test
Volume Forecast by Assay
France, All Market Segments,
Immunoprotein Test Volume Forecast by Assay
France, Hospital Laboratories,
France, All Market Segments, TDM
Test Volume Forecast by Assay
France, Hospital Laboratories, TDM
Test Volume Forecast
TDM Test Volume Forecast by Assay
France, All Market Segments, Drugs
of Abuse Test Volume Forecast by Assay
France, Hospital Laboratories, Drugs
Drugs of Abuse Test Volume Forecast by Assay
France, Total Clinical Chemistry and Reagent
Market Immunoassay Forecast By Test Category
France, Clinical Chemistry and
Immunoassay Calibrator and Control Market
Forecast By Test Category
France, Routine Chemistry Reagent Market



France, Endocrine Function Reagent Market
France, Tumor Markers and Special Chemistry
Reagent Market Forecast By Market Segment
France, Immunoprotein Reagent Market
France, TDM Reagent Market Forecast By
Market Segment
France, Drugs of Abuse Reagent Market
France, All Market Segments, Routine
Chemistry Reagent Market Forecast by Assay
France, Hospital Laboratories, Routine
Routine Chemistry Reagent Market Forecast by Assay
France, All Market Segments, Endocrine
Function Reagent Market Forecast by Assay
France, Hospital Laboratories, Endocrine
Endocrine Function Reagent Market Forecast by Assay
France, All Market Segments, Tumor Markers
and Special Chemistry Reagent Market Forecast by Assay
France, Hospital Laboratories, Tumor Markers
Tumor Markers and Special Chemistry Reagent
Market Forecast by Assay
France, All Market Segments,
Immunoprotein Reagent Market Forecast by Assay
France, Hospital Laboratories,
France, All Market Segments, TDM
Reagent Market Forecast by Assay
France, Hospital Laboratories, TDM
TDM Reagent Market Forecast by Assay
France, All Market Segments, Drugs of
Abuse Reagent Market Forecast by Assay
France, Hospital Laboratories, Drugs of
Drugs of Abuse Reagent Market Forecast by Assay



France, Clinical Chemistry and Immunoassay
Instrument Market Forecast By Analyzer Type
France, Major Suppliers of Clinical
Chemistry Diagnostics Products, Estimated Sales
and Market Shares
France, Major Suppliers of Immunoassay
Diagnostic Products, Estimated Sales and
Market Shares
Executive Summary Table: Germany, Clinical
Germany, Laboratories Performing Chemistry
Germany, Hospital Laboratories Performing
Chemistry and Immunoassay Tests By Bed Size
Germany, Commercial/Private Laboratories
Germany, Total Chemistry and Immunoassay
Germany, All Market Segments, Specimen
Germany, Total Clinical Chemistry and
Immunoassay Test Volume Forecast By Test Category
Germany, Routine Chemistry Test Volume
Germany, Endocrine Function Test Volume
Germany, Tumor Markers and Special
Chemistry Test Volume Forecast By Market
Segment
Germany, Immunoprotein Test Volume
Germany, TDM Test Volume Forecast By Market
Segment
Germany, Drugs of Abuse Test Volume
Germany, All Market Segments, Profiles,
Germany, Hospital Laboratories, Profiles,
Germany, Commercial/Private Laboratories,
Germany, Physician Offices/Group Practices,
Germany, All Market Segments, Routine
Germany, Hospital Laboratories, Routine



Germany, All Market Segments, Endocrine
Germany, Hospital Laboratories, Endocrine
Germany, All Market Segments, Tumor Markers
Germany, Hospital Laboratories, Tumor Markers
Germany, Commercial/Private Laboratories, Tumor
Markers and Special Chemistry Test Volume
Forecast by Assay
Germany, Physician Offices/Group
Practices, Tumor Markers and Special
Germany, All Market Segments,
Germany, Hospital Laboratories,
Germany, All Market Segments, TDM
Germany, Hospital Laboratories, TDM
Test Volume Forecast
Practices, TDM Test Volume Forecast by Assay
Germany, All Market Segments, Drugs
Germany, Hospital Laboratories, Drugs
Germany, Total Clinical Chemistry and Immunoassay



Reagent Market Forecast By Test Category
Germany, Clinical Chemistry and
Germany, Routine Chemistry Reagent Market
Germany, Endocrine Function Reagent Market
Germany, Tumor Markers and Special Chemistry
Germany, TDM Reagent Market Forecast By
Market Segment
Germany, Immunoprotein Reagent Market
Germany, Drugs of Abuse Reagent Market
Germany, All Market Segments, Routine
Germany, Hospital Laboratories, Routine
Germany, All Market Segments, Endocrine
Germany, Hospital Laboratories, Endocrine
Germany, All Market Segments, Tumor Markers
Germany, Hospital Laboratories, Tumor Markers
Germany, All Market Segments, TDM
Germany, Hospital Laboratories, TDM



Practices, TDM Reagent Market Forecast by Assay
Germany, All Market Segments,
Germany, Hospital Laboratories,
Immunoprotein Reagent Market Forecast
Germany, All Market Segments, Drugs of
Germany, Hospital Laboratories, Drugs of
Germany, Major Suppliers of Clinical
Chemistry Reagents, Estimated Sales and
Market Shares
Chemistry Analyzers, Estimated Instrument
Sales and Market Shares
and Market Shares
Germany, Major Suppliers of
Immunoassay Reagents, Estimated Sales
and Market Shares
Germany, Major Suppliers of Immunoassay
Analyzers, Estimated Instrument Sales and
Market Shares
Germany, Major Suppliers of Immunoassay
Market Shares
Germany, Clinical Chemistry and Immunoassay
Executive Summary Table: Italy, Clinical
Italy, Laboratories Performing Chemistry
Italy, Hospital Laboratories Performing
Chemistry and Immunoassay Tests
By Bed Size
Italy, Commercial/Private Laboratories



Italy, Total Chemistry and Immunoassay
Italy, All Market Segments, Specimen
Italy, Total Clinical Chemistry and Immunoassay
Test Volume Forecast By Test Category
Italy, Routine Chemistry Test Volume
Italy, Endocrine Function Test Volume
Italy, Tumor Markers and Special Chemistry
Italy, Immunoprotein Test Volume
Italy, TDM Test Volume Forecast By Market
Segment
Italy, Drugs of Abuse Test Volume
Italy, All Market Segments, Profiles,
Italy, Hospital Laboratories, Profiles,
Italy, Commercial/Private Laboratories,
Italy, All Market Segments, Routine
Italy, Hospital Laboratories, Routine
Italy, All Market Segments, Endocrine
Italy, Hospital Laboratories, Endocrine
Italy, All Market Segments, Tumor Markers
Italy, Hospital Laboratories, Tumor Markers
Italy, Commercial/Private Laboratories, Tumor
Markers and Special Chemistry Test Volume
Forecast by Assay
Italy, All Market Segments,
Italy, Hospital Laboratories,



Italy, All Market Segments, TDM
Italy, Hospital Laboratories, TDM
Italy, All Market Segments, Drugs
Italy, Hospital Laboratories, Drugs
Italy, Total Clinical Chemistry and Immunoassay
Reagent Market Forecast By Test Category
Italy, Clinical Chemistry and
Italy, Routine Chemistry Reagent Market
Italy, Endocrine Function Reagent Market
Italy, Tumor Markers and Special Chemistry
Italy, TDM Reagent Market Forecast By Market Segment
Italy, Immunoprotein Reagent Market
Italy, Drugs of Abuse Reagent Market
Italy, All Market Segments, Routine
Italy, Hospital Laboratories, Routine
Italy, All Market Segments, Endocrine
Italy, Hospital Laboratories, Endocrine
Italy, All Market Segments, Tumor Markers
Italy, Hospital Laboratories, Tumor Markers



Market Forecast by Assay by Assay
Italy, All Market Segments,
Italy, Hospital Laboratories,
Italy, All Market Segments, TDM
Italy, Hospital Laboratories, TDM
Italy, All Market Segments, Drugs of
Italy, Hospital Laboratories, Drugs of
Italy, Clinical Chemistry and Immunoassay
Italy, Major Suppliers of Clinical
and Market Shares
Italy, Major Suppliers of Immunoassay
Market Shares
Executive Summary Table: Japan, Clinical
Japan, Laboratories Performing Chemistry and
Immunoassay Testing By Market Segment
Japan, Hospital Laboratories Performing
Chemistry and Immunoassay Tests By Bed Size
Japan, Commercial/Private Laboratories
Performing Chemistry and Immunoassay Tests
By Annual Test Volume
Japan, Total Chemistry and Immunoassay
Japan, All Market Segments, Specimen Volume
Japan, Total Clinical Chemistry and Immunoassay
Test Volume Forecast By Test Category
Japan, Routine Chemistry Test Volume
Japan, Endocrine Function Test Volume
Japan, Tumor Markers and Special Chemistry



Japan, Immunoprotein Test Volume
Japan, TDM Test Volume Forecast By Market
Segment
Japan, Drugs of Abuse Test Volume
Japan, All Market Segments, Profiles,
Japan, Hospital Laboratories, Profiles,
Japan, Commercial/Private Laboratories,
Japan, All Market Segments, Routine
Japan, Hospital Laboratories, Routine
Japan, All Market Segments, Endocrine
Japan, Hospital Laboratories, Endocrine
Japan, All Market Segments, Tumor Markers
Japan, Hospital Laboratories, Tumor Markers
Tumor Markers and Special Chemistry Test
Volume Forecast by Assay
Japan, All Market Segments,
Japan, Ho


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